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Brachytherapy

TheraShere in treatment of primary & secondary liver carcinoma for Liver Cancer

N/A
Waitlist Available
Led By Parvez Mantry, M.D.
Research Sponsored by Methodist Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Patients over 18 years of age, of any race or sex, who have hepatocellular carcinoma of the liver, and who are able to give informed consent, will be eligible. Patients must have an ECOG Performance Status score of ≤ 2, with a life expectancy of ≥ 3 months, non-pregnant with an acceptable contraception in premenopausal women. Patients must be \>4 weeks since prior radiation or prior surgery and at least 1 month post chemotherapy.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 21 after the first treatment till 24 months
Awards & highlights

Summary

This trial is for a device called TheraSphere that is used to treat cancer in the liver. The device is commercially distributed under an HDE (humanitarian device exemption) and the objective of the trial is to provide supervised access to the therapy and to evaluate the response to treatment, survival time, and any associated toxicities and adverse experiences. Up to 100 patients per year are enrolled, with lab parameters and pregnancy tests done to confirm suitability for treatment. Follow up visits are scheduled for 3 months, 24 months, and in between treatments.

Eligible Conditions
  • Liver Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 21 after the first treatment till 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 21 after the first treatment till 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate SAE's associated with TheraSphere® treatment

Trial Design

1Treatment groups
Experimental Treatment
Group I: TheraShere in treatment of primary & secondary liver carcinomaExperimental Treatment1 Intervention
TheraSphere® is delivered into the liver tumor through a catheter placed into the hepatic artery. The hepatic artery provides the main blood supply to the tumor in the liver, whereas the portal vein supplies blood to normal liver parenchyma. TheraSphere® is embolized within the tumor and exerts a local beta radiation radiotherapeutic effect with a relatively limited concurrent injury to surrounding normal tissue.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TheraSphere
2007
Completed Early Phase 1
~2150

Find a Location

Who is running the clinical trial?

Methodist Health SystemLead Sponsor
152 Previous Clinical Trials
4,825,446 Total Patients Enrolled
Parvez Mantry, M.D.Principal InvestigatorMethodist Health System
1 Previous Clinical Trials
56 Total Patients Enrolled
~17 spots leftby Sep 2025
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